Method and Apparatus for Anastomosis Including an Anchoring Sleeve

ABSTRACT

Apparatus for performing a surgical anastomosis include a tubular body having an onion portion formed near the distal end of the tubular body. The apparatus includes a sleeve having a radius sized and dimensioned to slidably receive the tubular body therein. The apparatus includes a plunger assembly sized and dimensioned to be slidably received within the central lumen of the tubular body. The plunger assembly includes a distal end configured and adapted to deploy the onion portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation Application claiming thebenefit of and priority to U.S. application Ser. No. 10/517,404, filedon Dec. 7, 2004, which is a U.S. National Stage Application claiming thebenefit of and priority to International Application Serial No.PCT/US2003/011691, filed on Apr. 16, 2003, which claims the benefit ofand priority to U.S. Provisional Application Ser. No. 60/390,780, filedon Jun. 20, 2002, the entire content of each of which being incorporatedherein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to apparatus and methods for joiningtissue portions and, more particularly to anastomotic devices andmethods for positioning and joining body vessels using an anchoringsleeve.

2. Background of Related Art

Anastomosis is the joining of two hollow or tubular structures. Certainbody conduits are generally cylindrical in configuration and have acircular cross-section. When it is desired to suture such a conduit,typically for attachment to another body conduit, sutures are placedaround the circumference of the conduit in order to maintain the patencyof its lumen or channel. It can be appreciated that the sutures made ontop of the conduit (i.e., on the side facing the surgeon) are maderelatively more easily than the sutures made underneath the conduit(i.e., on the side facing away from the surgeon).

The complexity of joining two body vessels is made manifestly apparentin a surgical procedure referred to generally as a radical prostatectomy(i.e., a well established surgical procedure for patients with localizedprostatic carcinoma). In general, radical prostatectomy proceduresrequire the removal of cancerous tissue while preserving sexual functionand continence in the patient. There are two primary types of radicalprostatectomy approaches for the removal of prostate cancer, theretropubic approach and the perineal approach.

In the retropubic approach, a long up-and-down incision is made in themidline of the abdomen from the navel to the pubic bone. After the lymphnodes have been removed for study by the pathologist and a determinationhas been made to proceed with the removal of the prostate gland, thespace underneath the pubic bone is cleaned and dissected and the removalof the entire prostate gland is generally begun at the end that isfarthest from the bladder, i.e., next to the external urethralsphincter. Next, the prostatic urethra is divided, the prostatic urethraand the prostate gland through which it goes are then pulled upwardstoward the bladder while the dissection continues behind the prostategland, separating it from the layer of tissue that is connected to therectum on its other side. As the dissection continues between theprostate and the rectum, the seminal vesicles, which are behind the baseof the bladder will be removed along with the prostate gland. Once theseminal vesicles are free, the entire prostate gland and the seminalvesicles are removed. The bladder neck is then stitched closed to asmall enough diameter so that it is about the same size as the stump ofthe urethra from which the prostate was detached. The bladder neck isthen pulled down into the pelvis and positioned against the urethralstump and stitched thereto. This stitching is done typically around aFoley catheter which has been inserted through the penis all the wayinto the bladder.

In the perineal approach, an inverted “U” shaped incision is made goingright over the anus, with the center of the “U” about three centimetersabove the margin of the anus. The prostate gland is then freed from itssurrounding structures by gentle dissection, and the urethra at the endof the prostate farthest from the bladder is isolated and divided. Thebladder neck is freed from the prostate, and, once the prostate glandhas been removed and the bladder neck has been closed sufficiently sothat the size of its opening approximates the size of the urethralopening, the urethra and the bladder neck are stitched together. Onceagain, a Foley catheter is left in place postoperatively for about twoweeks.

In each of the above described procedures, it is the attachment of theurethral stump to the bladder neck which is particularly difficult andcomplex. This difficulty is complicated by the tendency of the urethralstump to retract into adjacent tissue. As a result, considerable timeand effort must be expended to re-expose the urethral stump and beginthe re-anastomosis procedure. Further complicating this procedure is thefact that the urethral stump is hidden beneath the pubic bone thusrequiring that the surgeon work at a difficult angle and in positionsthat are uncomfortable and limiting.

Various devices have been proposed for facilitating this procedure. InU.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed asuturing device including a shaft with portions defining an interiorchannel extending between a proximal and a distal end of the shaft. Thischannel includes a generally axial lumen which extends to the proximalend of the shaft and a generally transverse lumen which extends from theaxial lumen distally outwardly to an exit hole at the outer surface ofthe shaft. A needle and suture can be back loaded into the transverselumen of the channel while a generally non-compressible member can bemovably mounted in the axial lumen of the channel. At the proximal endof the shaft a handle is provided with means operative to push themember distally through the lumen to deploy or expel the needle.

In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a sutureguide with a curved distal portion. The distal portion of the sutureguide has a plurality of exterior axial grooves which can be used toalign and guide a curved needle and attached suture. In order to drivethe urethral stump to an accessible position, the device is providedwith a plurality of outwardly extendable members which engage the lumenof the urethra. These members make it possible to push the urethralstump into approximation with the bladder neck.

In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In general, none of the devices disclosed in the prior art referencesabove is simple to use or makes the anastomosis of the urethral stump tothe bladder neck easier. As such, each surgical procedure using priorart devices continues to be time consuming and requires great skill inorder to be performed. Accordingly, the need exists for anastomosisdevices which overcome the drawbacks of the prior art devices and whichare quick and simple to use.

SUMMARY OF THE INVENTION

Apparatus and methods for performing a surgical anastomotic procedureare disclosed herein. Apparatus according to the present disclosureinclude a tubular body having a proximal end, a distal end and an onionportion formed near the distal end of the tubular body for engaging afirst body vessel. The onion portion has a first position within aradial dimension of the tubular body and a second position outside theradial dimension of the tubular body. The apparatus includes a sleevehaving an expandable cuff for engaging the second body vessel. Thesleeve has a lumen for receiving the tubular body. The apparatusincludes a plunger assembly for being recalled in the tubular body. Theplunger assembly has a distal end arranged for deploying the onionportion from the first position to the second position.

Preferably, the tubular body has a first position in which the onionsleeve portion is substantially co-linear with or within the radialdimension of the tubular body and a second position in which the onionsleeve portion is deployed transversely with respect to the tubularbody. The tubular body desirably has a radius and defines a centrallumen having a radius.

In accordance with an embodiment of the present disclosure, the onionsleeve portion includes a plurality of longitudinally oriented slotsdefining a plurality of ribs. The ribs desirably include at least oneflexure line. Preferably, each rib includes a distal flexure line, aproximal flexure line and an intermediate flexure line between thedistal and proximal flexure lines. Most preferably, each intermediateflexure line is a double articulating joint. In is envisioned that theonion sleeve portion defines a radius about the intermediate flexurelines which is less than the radius of the tubular body.

In accordance with the present disclosure at least one of the pluralityof ribs includes a barb extending therefrom for engaging the first bodyvessel. Preferably, each barb does not extend beyond the radius of thetubular body while the onion sleeve portion is in the first position.More preferably, each barb is formed on the rib at a location betweenthe proximal flexure line and the intermediate flexure line. It iscontemplated that each barb is oriented in a substantially proximaldirection when the onion sleeve portion is in the second position.

In certain preferred embodiments, the onion portion has at least oneexpanded portion disposed outside the radial dimension of the tubularbody when the onion portion is in the second position. The onion portionmay have two expanded portions for engaging the first body vesseltherebetween.

In accordance with an alternative embodiment of the present disclosure,it is envisioned that each rib of the onion sleeve portion includes adistal flexure line, a proximal flexure line, a pair of central flexurelines, a first intermediate flexure line between the distal the pair ofcentral flexure lines and a second intermediate flexure line between theproximal flexure lines and the central flexure lines. Preferably, eachfirst intermediate flexure line is a double articulating joint. Morepreferably, the onion sleeve portion defines a radius about the firstintermediate flexure lines which is less than the radius of the tubularbody.

It is envisioned that at least one of the plurality of ribs includes abarb extending therefrom, wherein each barb does not extend beyond theradius of the tubular body while the onion sleeve portion is in thefirst position. It is contemplated that each barb is formed on the ribat a location between the first intermediate flexure lines and thecentral flexure lines. Preferably, each barb is oriented in asubstantially proximal direction when the onion sleeve portion is in thesecond position.

It is further contemplated that the head portion of the plunger assemblyis provided with an engaging element configured and adapted toselectively couple with an engaging element provided at the distal endof the tubular body.

A preferred method of joining a first body vessel and a second bodyvessel comprises passing an apparatus through the second body vessel,the apparatus having an onion portion so that the onion portion isreceived in the first body vessel. The onion portion is deployed so thatthe onion portion moves to a position outside the radial dimension ofthe tubular body. The first body vessel and second body vessel areapproximated and joined.

The method further includes the step of expanding an expandable cuff toengage the second body vessel. The apparatus may include a sleeve havingthe expandable cuff and the method may include moving the tubular bodyand the sleeve with respect to one another so as to approximate thefirst and second body vessels. The apparatus may have a plunger assemblyfor deploying the onion portion and the method may include advancing theplunger assembly so as to deploy the onion portion. The position of thetubular body and sleeve are desirably secured with respect to oneanother.

These and other features of the apparatus and method disclosed herein,will become apparent through reference to the following description ofembodiments, the accompanying drawings and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the present disclosure.

FIG. 1 is a perspective view of an anastomosis apparatus, in accordanceto an embodiment of the present disclosure, shown in an insertioncondition;

FIG. 2 is a perspective view of the anastomosis apparatus of FIG. 1,shown in a deployed condition;

FIG. 3 is a partial cross-sectional perspective view of a portion of aurinary system with the anastomosis apparatus of FIG. 1, shown in theinsertion condition, and illustrating the anastomosis apparatus beingpassed through a body lumen and entering a hollow body organ;

FIG. 4 is partial cross-sectional perspective view of the urinary systemwith the anastomosis apparatus of FIG. 1, with the radially expandableonion sleeve shown in a deployed condition within the hollow body organand the radially expandable cuff shown in a deployed condition withinthe body lumen;

FIG. 5 is a cross-sectional side elevational view of the apparatus ofFIG. 1, depicting the approximation of the hollow body organ to the bodylumen;

FIG. 6 is a perspective view of an anastomosis apparatus, in accordanceto another embodiment of the present disclosure, shown in an insertioncondition; and

FIG. 7 is a cross-sectional side elevational view of the anastomosisapparatus of FIG. 6, depicting the approximation of the hollow bodyorgan to the body lumen.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed anastomosis apparatuswill now be described in detail with reference to the drawing figureswherein like reference numerals identify similar or identical elements.In the drawings and in the description which follows, the term“proximal”, as is traditional will refer to the end of the surgicaldevice or instrument of the present disclosure which is closest to theoperator, while the term “distal” will refer to the end of the device orinstrument which is furthest from the operator.

Referring now to FIGS. 1-5, an anastomosis apparatus, in accordance withthe principles of the present disclosure, is shown generally asreference numeral 100. Although apparatus 100 offers significantadvantages to a radical prostatectomy procedure, it will be understoodthat the device is applicable for use in any anastomotic procedure wheretwo body vessels are to be approximated and/or joined, includingapproximating and/or joining the urethra and bladder, intestinalportions of the body, blood vessels, and any other body vessels.

As seen in FIG. 1, apparatus 100 includes a tubular body 102, a sleeve104 slidably received about tubular body 102 and a plunger assembly 106slidably received within tubular body 102. Tubular body 102 includes aproximal end 108 and a distal end 110 and defines a central lumen 112extending therethrough which central lumen 112 defines a centrallongitudinal axis “X”.

Tubular body 102 includes an expandable anchor or onion sleeve portion114 formed near distal end 110. In accordance with the presentdisclosure, onion sleeve portion 114 includes a plurality of radiallyformed, longitudinally oriented, elongated slots 116. Slots 116 define aplurality of longitudinally oriented ribs 118, each desirably having aplurality of transverse flexure lines 120 formed along the lengththereof or being otherwise flexible. Preferably, ribs 118 include adistal and a proximal flexure line 120A, 120B, respectively, and anintermediate flexure line 120C. In one preferred embodiment,intermediate flexure line 120C is a double articulating flexure line,i.e., a flexure line which can be bent in two directions.

In accordance with the present disclosure, onion sleeve portion 114 hasa biased retracted position, as seen in FIG. 1, in which a radius ofonion sleeve portion 114, about intermediate flexure lines 120C, is lessthan a radius of tubular body 102. Onion sleeve portion 114 has anunbiased expanded position, as seen in FIG. 2, in which the radius ofonion sleeve 114, about intermediate flexure lines 120C, is greater thanthe radius of tubular body 102. In the embodiment shown, when onionsleeve portion 114 is in the expanded position. the portion of each rib118 between intermediate flexure line 120C and proximal flexure line120B is disposed at an angle with respect to the longitudinal “X” axis.

Onion sleeve portion 114 of tubular body 102 further desirably includesat least one barb 122 extending outwardly from each rib 118 and in aproximal direction. In accordance with the present disclosure, whenonion sleeve portion 114 is in the retracted position, barbs 122 do notextend beyond the radial boundary of tubular sleeve 102. In this manner,barbs 122 do not interfere with the passage of tubular body 102 throughsleeve 104. Further, in accordance with the present disclosure, whenonion sleeve portion 114 is in the expanded position, it is preferredthat barbs 122 are oriented substantially in a proximal direction andare substantially co-linear with the longitudinal “X” axis. While barbs122 are preferred for penetrating body tissue, it is envisioned that theouter surface of rib 118 can be roughened in order to increase thegripping effect of rib 118 when in contact with body tissue.

It is contemplated that onion sleeve portion 114 and barbs 122 are madefrom a medical grade material, such as, for example, stainless steel ortitanium, however, it is preferred that onion sleeve portion 114 andbarbs 122 are made from a medical grade bio-absorbable material, suchas, for example, polyglycolic acid (PGA) and/or polylactic acid (PLA).

As seen in the figures, distal end 110 of tubular body 102 is providedwith a blunt end cap 124. However, tubular body 102 may have a distalend which opens into central lumen 112.

Sleeve 104 includes a distal end 130 and a proximal end (not shown)defining a lumen 132 extending therethrough. It is envisioned thatdistal end 130 of sleeve 104 can be tapered in order to facilitatepassage of sleeve 104 through the body lumen. In accordance with thepresent disclosure, sleeve 104 includes an expandable cuff 134 providednear distal end 130 thereof. Preferably, expandable cuff 134 has a firstposition in which expandable cuff 134 has a radius which is less than orequal to a radius of sleeve 104 and a second position in whichexpandable cuff 134 has a radius which is greater than the radius ofsleeve 104.

It is envisioned that sleeve 104 is provided with an inflation/deflationlumen (not shown) extending along the length thereof and which is influid communication with expandable cuff 134 through at least one accessopening (not shown) formed in sleeve 104. In use, theinflation/deflation lumen is coupled to a source of inflation fluid (notshown) and a fluid is injected through the inflation/deflation lumen inorder to inflate and expand cuff 134 to an expanded condition andthereby anchor or fix the placement of sleeve 104 within the body lumen.Concomitantly, withdrawal of the fluid used to inflate and expand cuff134 will cause cuff 134 to deflate and thereby allow sleeve 104 to bewithdrawn from the body lumen.

Expandable cuff 134 is preferably fabricated from a medical gradepolymer having suitable flexibility and structural integrity towithstand the forces associated with the inflation of cuff 134 and withthe function of anchoring sleeve 104 within the body lumen.

At least one annular seal, i.e., an O-ring, (not shown) is desirablyprovided between tubular body 102 and sleeve 104. The annular sealprevents or reduces the possibility of fluids from passing betweentubular body 102 and sleeve 104.

Plunger assembly 106 includes a shaft 140 having a distal end 142, aproximal end (not shown) and a head portion 144 operatively coupled todistal end 142. In the embodiment shown, head portion 144 is preferablydimensioned to be received within central lumen 112 of tubular body 102.More preferably, head portion 144 defines a circular outer surfacehaving an outer radius slightly smaller than the inner radius of tubularbody 102

It is envisioned that the outer surface of head portion 144 is providedwith a coupling element (not shown) configured and adapted to engage acorresponding coupling element (not shown) formed in either the innersurface of the distal end 110 of tubular body 102 or on the innersurface of end cap 124 of tubular body 102. It is contemplated that thecoupling element formed on head portion 144 could be a helical threadwhich is configured and adapted to engage a corresponding helical threadformed on the inner surface of distal end 110 of the tubular body 102 ata location distal of onion sleeve portion 114. It is furthercontemplated that the coupling elements of head portion 144 and ofdistal end 110 of tubular body 102 may form a bayonet type coupling.

As will be described in greater detail below, in use, as plungerassembly 106 is distally advanced through central lumen 112 of tubularbody 102, head portion 144 of plunger assembly 106 first engages theinner surface of ribs 118. As head portion 144 of plunger assembly 106is further distally advanced, past onion sleeve portion 114, headportion 144 presses ribs 118 radially outward. In so doing, onion sleeve114 goes from the biased retracted position to the unbiased expandedposition, as discussed above. Head portion 144 is then further advanceduntil the coupling element of head portion 144 engages the couplingelement formed at distal end 110 of tubular body 102.

It is envisioned that apparatus 100 be provided with a locking mechanismfor securing tubular body 102 to sleeve 104 and to prevent theirrelative movement with respect to one another.

A preferred method of use and operation of anastomosis apparatus 100 ina radical anastomotic procedure will now be described in greater detailwith reference to FIGS. 1-5 and in particular with reference to FIGS.3-5. Apparatus 100 can be used in either the retropubic or the perinealprostatectomy approaches. With the prostate removed, the bladder neck“N” of the bladder “B” is first reconstructed by everting the innermucosal lining of bladder “B” and suturing it down to the outer wall ofbladder “B” using known surgical techniques. Likewise, urethral stump“S” of urethra “U” is reconstructed by everting the inner mucosal liningof urethral stump “S” and suturing it down to the outer wall of urethra“U”, using known surgical techniques.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate and retain distal end 108 of tubular body102 within bladder “B” using a standard tennis racket type closure(i.e., the opening of the bladder neck constituting the head of thetennis racket and a radial incision extending from the bladder neckconstituting the handle portion of the tennis racket. Most preferably,bladder neck “N” is sized to be approximately 7-8 mm in diameter.

With bladder neck “N” reconstructed, apparatus 100, including tubularbody 102 and sleeve 104, is passed trans-urethrally through urethra “U”until distal end 110 of tubular body 102 extends out of urethral stump“S” and into bladder through bladder neck “N”, as indicated by arrow “A”in FIG. 3. In particular, distal end 110 of tubular body 102 ispreferably positioned such that expandable onion sleeve portion 114 oftubular body 102 is positioned entirely within bladder “B”. In addition,distal end 130 of sleeve 104 is preferably positioned such thatexpandable cuff 134 is positioned near urethral stump “S” of urethra“U”.

With tubular body 102 positioned within bladder “B”, plunger assembly106 is distally advanced through central lumen 112 of tubular body 102.As described above, as plunger assembly 106 is distally advanced throughcentral lumen 112 of tubular body 102, head portion 144 of plungerassembly 106 first engages the inner surface of ribs 118. As headportion 144 of plunger assembly 106 is further distally advanced, pastonion sleeve portion 114, head portion 144 presses ribs 118 radiallyoutward. In so doing, onion sleeve portion 114 is deployed from thebiased retracted position to the unbiased expanded position. As such,barbs 122 of ribs 118 of onion sleeve portion 114 become oriented in asubstantially proximal direction. Head portion 144 is then furtheradvanced until the coupling element of head portion 144 engages thecoupling element formed at distal end 110 of tubular body 102.

With head portion 144 of plunger assembly 106 coupled to distal end 110of tubular body 102 and onion sleeve portion 114 in the expandedposition, either plunger assembly 106 or both plunger assembly 106 andtubular body 102 are pulled in a proximal direction through urethra “U”as indicated by arrows “D”. By pulling at least tubular body 102 in aproximal direction, barbs 122 of onion sleeve portion 114 are driveninto the wall of bladder “B”.

With sleeve 104 positioned near urethral stump “S”, a fluid (i.e., air,carbon dioxide, saline or the like) is introduced into cuff 134 tothereby expand and inflate cuff 134. Inflation of cuff 134 results inthe radial expansion of cuff 134 and in turn the pressing of cuff 134against the inner surface of urethra “U”, thus preventing axial movementof sleeve 104 through urethra “U”.

With onion sleeve portion 114 of tubular body 102 anchored in bladder“B” and cuff 134 of sleeve 104 secured within urethra “U”, eithertubular body 102, plunger assembly 106 or both tubular body 102 andplunger assembly 106 are withdrawn in a proximal direction throughsleeve 104 in order to approximate bladder “B” to urethra “U”. Oncebladder “B” has been approximated into contact with urethra “U”, tubularbody 102 is locked in position with respect to sleeve 104 therebymaintaining bladder “B” approximated with urethra “U”. The body 102 maybe fixed in relation to sleeve 104 using a latch, or any other knownmeans.

With tubular body 102 fixed in position with respect to sleeve 104, headportion 144 of plunger assembly 106 is disengaged from distal end 110 oftubular body 102 and plunger assembly 106 is withdrawn therefrom. It isenvisioned that, with plunger assembly 106 removed from central lumen112 of tubular body 102, that tubular body 102 and sleeve 104 act like aFoley-type catheter to create a passage, defined by slots 116 andcentral lumen 112, through which body fluid (i.e., urine) is permittedto pass from bladder “B” and out through urethra “U”.

In accordance with the present disclosure, it is preferred that tubularbody 102 and sleeve 104 are maintained within bladder “B” and urethra“U” for a period of several weeks or for a period of time sufficient forbladder neck “N” and urethral stump “S” to heal and “grow” together.Once bladder neck “N” and urethral stump “S” have sufficiently healed,and barbs 122 sufficiently dissolved and absorbed within the body, onionsleeve portion 114 and cuff 134 are retracted and tubular body 102 andsleeve 104 are withdrawn from urethra “U”.

The expandable anchor for engaging the first and/or second body vesselmay comprise any expandable structure, including those disclosed incertain embodiments of the following PCT applications, all filed on aneven date herewith: Application Entitled Method And Apparatus ForAnastomosis Including An Anchoring Sleeve, invented by Scott Manzo;Method And Apparatus For Anastomosis Including An Anchoring Sleeve,invented by Scott Manzo; Method And Apparatus For Anastomosis IncludingAnnular Joining Member, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including Annular Joining Member, invented by ScottManzo; Method And Apparatus For Anastomosis Including An ExpandableMember, invented by Russell Heinrich and Scott Manzo; Method AndApparatus For Anastomosis Including An Expandable Anchor, invented byRussell Heinrich and Scott Manzo (Ref. No. 2798); the disclosures ofwhich are all hereby incorporated by reference herein, in theirentirety.

The joining member for joining the first and/or second body vessel maycomprise any joining member, including those disclosed in certainembodiments of the following PCT Applications: Method And Apparatus ForAnastomosis Including An Anchoring Sleeve, invented by Scott Manzo;Method And Apparatus For Anastomosis Including Annular Joining Member,invented by Scott Manzo; Method And Apparatus For Anastomosis IncludingAnnular Joining Member, invented by Scott Manzo; Method And ApparatusFor Anastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Expandable Member, invented by Russell Heinrichand Scott Manzo; Method And Apparatus For Anastomosis Including AnExpandable Anchor, invented by Russell Heinrich and Scott Manzo; thedisclosures of which are all hereby incorporated by reference herein, intheir entirety.

Turning now to FIGS. 7 and 8, an anastomosis apparatus, in accordancewith an alternative embodiment of the disclosure, is shown generally asreference numeral 200. Apparatus 200 includes a tubular body 202, asleeve 204 slidably received about tubular body 202 and a plungerassembly 206 slidably received within tubular body 202. Tubular body 202includes a distal end 210 and a proximal end (not shown) and defines acentral lumen 212 extending therethrough which central lumen 212 definesa central longitudinal axis “X”.

Tubular body 202 includes an expandable onion sleeve portion 214 formednear distal end 210. In accordance with the present disclosure, onionsleeve portion 214 includes a plurality of radially formed,longitudinally oriented, elongated slots 216. Slots 216 define aplurality of longitudinally oriented ribs 218, each having a pluralityof transverse flexure lines 220 formed along the length thereof.Preferably, each rib 218 includes a distal flexure line 220A, a proximalflexure line 220B, a pair of central flexure lines 220C, 220D, a firstintermediate flexure line 220E formed between distal flexure line 220Aand central flexure line 220C and a second intermediate flexure line220F formed between proximal flexure line 220B and central flexure line220D.

In accordance with the present disclosure, flexure lines 220A-220F areconfigured and adapted such that onion sleeve portion 214 has aretracted position, as seen in FIG. 6, in which a radius of onion sleeveportion 214, about first intermediate flexure lines 220E, is less than aradius of tubular body 202. Onion sleeve portion 214 has an unbiasedposition, as seen in FIG. 7, in which the radius of onion sleeve 214,about intermediate flexure lines 220E, is greater than the radius of thetubular body 202. Preferably, when onion sleeve portion 214 is in theexpanded position, the portion of each rib 218 between firstintermediate flexure line 220E and central flexure line 220C isorthogonal with respect to the longitudinal “X” axis. Further, whenonion sleeve portion 214 is in the expanded position, the portion ofeach rib 218 between second intermediate flexure 220F and centralflexure line 220D is orthogonal with respect to the longitudinal “X”axis.

Onion sleeve portion 214 of tubular body 202 further includes at leastone barb 222 extending outwardly from each rib 218. Preferably, the atleast one barb 222 is provided on the portion of rib 218 between firstintermediate flexure line 220E and central flexure line 220C.Preferably, first intermediate flexure line 220E is a doublearticulating flexure line. Accordingly, when onion sleeve portion 214 isin the retracted position, barbs 222 do not extend beyond the radialboundary of tubular sleeve 202. In this manner, barbs 222 do notinterfere with the passage of tubular body 202 through sleeve 204.Further, in accordance with the present disclosure, when onion sleeveportion 214 is in the expanded position, it is preferred that barbs 222are oriented substantially in a proximal direction and are substantiallyparallel with the longitudinal “X” axis.

As seen in FIGS. 6 and 7, distal end 210 of tubular body 202 is providedwith a blunt end cap 224. However, it is envisioned that tubular body202 can have a distal end 210 which opens into central lumen 212.

Sleeve 204 includes a distal end 230 and a proximal end (not shown)defining a lumen 232 extending therethrough. It is envisioned thatdistal end 230 of sleeve 204 can be tapered in order to facilitatepassage of sleeve 204 through the body lumen. In accordance with thepresent disclosure, sleeve 204 includes an expandable cuff 234 providednear distal end 230 thereof. Preferably, expandable cuff 234 has a firstposition in which expandable cuff 234 has a radius which is less than orequal to a radius of sleeve 204 and a second position in whichexpandable cuff 234 has a radius which is greater than the radius ofsleeve 204.

It is envisioned that sleeve 204 is provided with an inflation/deflationlumen (not shown) extending along the length thereof and which is influid communication with expandable cuff 234 through at least one accessopening (not shown) formed in sleeve 204. In use, theinflation/deflation lumen is coupled to a source of inflation fluid (notshown) and a fluid is injected through the inflation/deflation lumen inorder to inflate and expand cuff 234 to an expanded condition andthereby anchor or fix the placement of sleeve 204 within the body lumen.Concomitantly, withdrawal of the fluid used to inflate and expand cuff234 will cause cuff 234 to deflate and thereby allow sleeve 204 to bewithdrawn from the body lumen.

It is contemplated that at least one annular seal, i.e., an O-ring, (notshown) may be provided between tubular body 202 and sleeve 204.Accordingly, it is envisioned that the annular seal prevents or reducesthe possibility of fluids from passing between tubular body 202 andsleeve 204.

Plunger assembly 206 includes a shaft 240 having a distal end 242, aproximal end (not shown) and a head portion 244 operatively coupled todistal end 242. In accordance with the present disclosure, head portion244 is preferably dimensioned to be received within central lumen 212 oftubular body 202. More preferably, head portion 244 defines a circularouter surface having an outer radius slightly smaller than the innerradius of tubular body 202

It is envisioned that the outer surface of head portion 244 is providedwith a coupling element, similar to coupling element of head portion144, configured and adapted to engage a corresponding coupling elementformed in either the inner surface of the distal end 210 of tubular body202 or on the inner surface of end cap 224 of tubular body 202.

In use, as plunger assembly 206 is distally advanced through centrallumen 212 of tubular body 202, head portion 244 of plunger assembly 206first engages the inner surface of ribs 218. As head portion 244 ofplunger assembly 206 is further distally advanced, past onion sleeveportion 214, head portion 244 presses ribs 218 radially outward. In sodoing, onion sleeve 214 goes from the biased retracted position to theunbiased expanded position, as discussed above. Head portion 244 is thenfurther advanced until the coupling element of head portion 244 engagesthe coupling element formed at distal end 210 of tubular body 202. Inother embodiments, other means are used to deploy the onion sleeveportion.

It is envisioned that apparatus 200 be provided with a locking mechanismfor securing tubular body 202 to sleeve 204 and to prevent theirrelative movement with respect to one another. The body 202 and sleeve204 may be secured using latch or any other means.

With bladder neck “N” reconstructed, apparatus 200, including tubularbody 202 and sleeve 204, is passed trans-urethrally through urethra “U”until distal end 210 of tubular body 202 extends out of urethral stump“S” and into bladder “B” through bladder neck “N”. In particular, distalend 210 of tubular body 202 is preferably positioned such that firstintermediate flexure line 220E is positioned distally of bladder neck“N” and second intermediate flexure line 220F is positioned proximallyof bladder neck “N”. In addition, distal end 230 of sleeve 204 ispreferably positioned such that expandable cuff 234 is positioned nearurethral stump “S” of urethra “U”.

With tubular body 202 so positioned with respect to bladder neck “N”,plunger assembly 206 is distally advanced through central lumen 212 oftubular body 202. As described above, as plunger assembly 206 isdistally advanced through central lumen 212 of tubular body 202, headportion 244 of plunger assembly 206 first engages the inner surface ofribs 218, in particular, the inner surface of ribs 218 disposed betweenfirst intermediate flexure line 220E and central flexure line 220C. Ashead portion 244 of plunger assembly 206 is further distally advanced,past onion sleeve portion 214, head portion 244 presses ribs 118radially outward. In so doing, onion sleeve portion 214 is deployed fromthe retracted position to the expanded position. As such, barbs 222 ofribs 218 of onion sleeve portion 214 become oriented in a substantiallyproximal direction. Head portion 244 is then further advanced until thecoupling element of head portion 244 engages the coupling element formedat distal end 210 of tubular body 202.

With head portion 244 of plunger assembly 206 coupled to distal end 210of tubular body 202 and onion sleeve portion 214 in the expandedposition, shaft 240 of plunger assembly 206 is pulled in a proximaldirection through tubular body 202, while holding tubular body 202 in afixed position. By pulling shaft 240 in a proximal direction and holdingtubular body 202 in a fixed position, second intermediate flexure line220F of onion sleeve portion 214 is expanded radially outward.

With barbs 222 oriented in a proximal direction, as shaft 240 is pulledin a proximal direction, onion sleeve portion 214, being a double onion,acts like a clamp to close down about bladder neck “N”. In so doing,barbs 222 are driven through bladder neck “N” while rib 218, betweencentral flexure line 220D and second intermediate flexure line 220F,acts to support the exterior surface of bladder neck “N”. It isenvisioned that the portion of each rib 218, between central flexureline 220D and second intermediate flexure line 220F, is provided with anopening for accommodating passage of barbs 222 therethrough during theclamping process. With barbs 222 anchored in the wall of bladder neck“N”, shaft 240 of plunger assembly 206 is moved in a proximal direction,with respect to tubular body 202, in order to return second intermediateflexure line 220F to the retracted position.

With sleeve 204 positioned near urethral stump “S”, a fluid isintroduced into cuff 234 to thereby expand and inflate cuff 234.Inflation of cuff 234 results in the radial expansion of cuff 234 and inturn the pressing of cuff 234 against the inner surface of urethra “U”,thus preventing axial movement of sleeve 204 through urethra “U”.

With onion sleeve portion 214 of tubular body 202 anchored in bladder“B” and cuff 234 of sleeve 204 secured within urethra “U”, eithertubular body 202, plunger assembly 206 or both tubular body 202 andplunger assembly 206 are withdrawn in a proximal direction throughsleeve 204 in order to approximate bladder “B” to urethra “U”. Oncebladder “B” has been approximated into contact with urethra “U”, tubularbody 202 is locked in position with respect to sleeve 204 therebymaintaining bladder “B” approximated with urethra “U.”.

With tubular body 202 fixed in position with respect to sleeve 204, headportion 244 of plunger assembly 206 is disengaged from distal end 210 oftubular body 202 and plunger assembly 206 is withdrawn therefrom. Inaccordance with the present disclosure, it is preferred that tubularbody 202 and sleeve 204 are maintained within bladder “B” and urethra“U” for a period of several weeks or for a period of time sufficient forbladder neck “N” and urethral stump “S” to heal and “grow” together.Once bladder neck “N” and urethral stump “S” have sufficiently healed,and barbs 222 sufficiently dissolved and absorbed within the body, onionsleeve portion 214 and cuff 234 are retracted and tubular body 202 andsleeve 204 withdrawn from urethra “U”.

While apparatus in accordance with the present disclosure have beendescribed as being used in connection with radical prostatectomyprocedures, it is envisioned that apparatus having similar structuresand modes of operation can be used in various other surgical procedures.It will be understood that various modifications may be made to theembodiments of the presently disclosed anastomosis devices and methodsdisclosed herein. For example, the onion sleeve portion may bedeployable by other means. One end of the ribs may be attached to asleeve that is moved proximally, bending the ribs outwardly. In otherembodiments, the body has arms that are deployed outwardly by the headportion of the plunger assembly or by some other means. Therefore, theabove description should not be construed as limiting, but merely as anexemplification of a preferred embodiment. Those skilled in the art willenvision other modifications within the scope of the present disclosure.

1-9. (canceled)
 10. A method of approximating a first body vessel and asecond body vessel, comprising: a) passing an apparatus through thesecond body vessel, the apparatus having a tubular body and anexpandable anchor formed near a distal end of the tubular body, so thatthe expandable anchor is received in the first body vessel; b) advancinga plunger assembly through the tubular body to deploy the expandableanchor so that the expandable anchor moves to a position outside aradial dimension of the tubular body; and c) withdrawing the expandableanchor in a proximal direction to approximate the first body vessel andthe second body vessel.
 11. The method according to claim 10, furthercomprising the step of deploying an expandable cuff so as to engage thesecond body vessel. 12-13. (canceled)